E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
pharmacokinetics of fluoroquinolones |
pharmacocinétique des fluoroquinolones |
|
E.1.1.1 | Medical condition in easily understood language |
pharmacokinetics of fluoroquinolones |
pharmacocinétique des fluoroquinolones |
|
E.1.1.2 | Therapeutic area | Not possible to specify |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
model the pharmacokinetics of fluoroquinolones by a analysis of population |
modéliser la pharmacocinétique des fluoroquinolones par une analyse de population |
|
E.2.2 | Secondary objectives of the trial |
- define a limited sampling scheme allowing the estimation of area under the curve concentrations of the antibiotic
- determine the pharmacokinetic-pharmacodynamic index in specific subpopulations (ICU patients, patients treated for bone and joint infection) or bacteria for which the index is unknown (including staphylococci) |
- définir un schéma limité de prélèvements autorisant l’estimation de l’aire sous la courbe des concentrations de l’antibiotique
- déterminer les index pharmacocinétique-pharmacodynamique dans des sous-populations particulières (patients de réanimation, patients traités pour une infection ostéo-articulaire) ou pour des bactéries pour lesquelles ces index sont inconnus (Staphylocoques notamment) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age> 18 years
- Medical Intensive Care : Infection treated with ciprofloxacin IV
- Orthopedics: staph infection treated with oral ofloxacin
- Free and informed consent in writing |
- Age > 18 ans
- Réanimation médicale : Infection traitée par ciprofloxacine IV
- Orthopédie : Infection par staphylocoque traitée par ofloxacine per os
- Consentement libre et éclairé par écrit |
|
E.4 | Principal exclusion criteria |
- Pregnant woman
- Person major subject to legal protection, person deprived of liberty |
- Femme enceinte
- Personne majeure faisant l’objet d’une protection légale, personne privée de liberté
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Measurement of plasma concentrations of ciprofloxacine and ofloxacine between two administrations (8-10 samples per patient) on the 4th day of treatment initiated by the usual criteria for management of the disease |
Mesure des concentrations plasmatiques de ciprofloxacine et ofloxacine entre 2 administrations (8 à 10 prélèvements par patient) au 4ème jour du traitement instauré selon les critères habituels de prise en charge de la pathologie |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
the 4th day of treatment initiated |
au 4ème jour du traitement instauré |
|
E.5.2 | Secondary end point(s) |
- Collection of demographic, biological and clinical data
- Comparison of pharmacokinetic parameters calculated or estimated (area under the concentration curve, maximum concentration) to the minimum inhibitory concentration (real or modal) fluoroquinolone interest in the bacteria treated |
- Recueil de données démographiques, biologiques et cliniques
- Comparaison des paramètres pharmacocinétiques calculés ou estimés (aire sous la courbe des concentrations, concentration maximale) à la concentration minimale inhibitrice (réelle ou modale) de la fluoroquinolone d’intérêt pour la bactérie traitée |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
the 4th day of treatment initiated |
au 4ème jour du traitement instauré |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
dernière visite du dernier patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |